Effect of botulinum toxin A in knee osteoarthritis

Comparison of ozone and botulinum toxin A injection in patients with knee osteoarthritis: a randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20151017024572N20

Enrollment

Registered

2019-10-28

Start date

2019-11-01

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Knee Osteoartheritis. Bilateral primary osteoarthritis of knee

Interventions

Intervention 1: Intervention group: Botulinum Toxin A injection will be performed under the ultrasound guidance in the knee joint which will be done by an experienced physical medicine and rehabilit

using supra patellar approach. Intervention 2: Intervention group: Ozone gas injection will be performed under the ultrasound guidance in the knee joint which will be done by an experienced physical m

using supra patellar approach.

Eligibility

Sex/Gender

All

Age

40 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with mild to moderate OA of the knee (Kellgren Lawrence grade I, II and III) Knee pain for at least six months ??Absence of any acute or chronic infection No pregnancy or lack of planning to get pregnant No history of any intra articular knee injection in the past three months Absence of inflammatory articular disease or secondary osteoarthritis No history of knee surgery No severe underlying disease such as uncontrolled diabetes none use of anticoagulant agents No daily use of opioid and non opioid analgesics

Exclusion criteria

Exclusion criteria: The willingness of patients to exit from the study at any stage of the study

Design outcomes

Primary

Measure	Time frame
?Severity of pain. Timepoint: Before intervention, 1, 4 and 12 weeks after intervention. Method of measurement: Visual Analog Scale(VAS).;The severity of symptoms and functional limitations. Timepoint: Before intervention, 1, 4 and 12 weeks after intervention. Method of measurement: WOMAC questionnare.;Range of motion. Timepoint: Before intervention, 1, 4 and 12 weeks after intervention. Method of measurement: Goniometer.	—

Measure

Time frame

?Severity of pain. Timepoint: Before intervention, 1, 4 and 12 weeks after intervention. Method of measurement: Visual Analog Scale(VAS).;The severity of symptoms and functional limitations. Timepoint: Before intervention, 1, 4 and 12 weeks after intervention. Method of measurement: WOMAC questionnare.;Range of motion. Timepoint: Before intervention, 1, 4 and 12 weeks after intervention. Method of measurement: Goniometer.

—

Secondary

Measure	Time frame
Side effects. Timepoint: 1,4, and 12 weeks after intervention. Method of measurement: Physical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSima Hosseinverdi

Iran University of Medical Sciences

Simahosseinverdi@gmail.com+98 21 4128 9221

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026